FDA.reportPublic FDA data

Amantadine Hydrochloride

Product NDC
50383-807
11-digit product format
503830807
Labeler code
50383
Product ID
50383-807_bc1acf38-57da-407d-a926-fa996e94bfff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Akorn
Application
ANDA074170
Marketing category
ANDA
Marketing start
1994-10-28
Marketing end
0000-00-00
Substance
AMANTADINE HYDROCHLORIDE
Active strength
50 mg/5mL
Pharmacologic classes
Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
519d6abc-639d-2962-cced-abbf8b16aad4Product name720250401
82f46845-b4c7-48da-a389-ba5721b956c9Product name220250325
d2c037c0-5ebf-d224-252f-2549922c21c7Product name720240208
b7b57a62-2f7f-1a22-2cb2-eaa5c08d4721Product name220220224
14e11aaf-885f-472f-a02a-c6a3f28df907Product name120180515
82f46845-b4c7-48da-a389-ba5721b956c9Product name120171103

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-807-122024-01-30C16284748780-11030e365-4120-111a-e063-dadaa90a10e2Amantadine Hydrochloride Oral Solution, USP
50383-807-162024-01-30C16284748780-11030e365-4120-111a-e063-dadaa90a10e2Amantadine Hydrochloride Oral Solution, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-807-10Amantadine Hydrochloride10 mL in 1 CUP, UNIT-DOSESOLUTION1010
50383-807-12Amantadine Hydrochloride10 in 1 CASESOLUTION1010
50383-807-12Amantadine Hydrochloride10 in 1 TRAYSOLUTION1010
50383-807-16Amantadine Hydrochloride473 mL in 1 BOTTLESOLUTION47310

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-807-10ML - Milliliter50383-80752425f69-8a09-4308-b9ba-0a275f2be64e12015-02-02
50383-807-12ML - Milliliter50383-807022703cc-a4e2-47a7-ba04-e844b8c282af12015-02-02
50383-807-16ML - Milliliter50383-8071ba5d6d4-da63-491d-8e79-f5edd839edfa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMANTADINE HYDROCHLORIDEACTIVE INGREDIENTM6Q1EO9TD0AMANTADINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]5
AMANTADINEACTIVE MOIETYBF4C9Z1J53AMANTADINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]5
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAMANTADINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMANTADINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAMANTADINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]5
SORBITOLINACTIVE INGREDIENT506T60A25RAMANTADINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RAMANTADINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-807AMANTADINE HYDROCHLORIDE SOLUTION [AKORN]10Legacy NDC, 4 package rows20220916_7ef565b0-00ac-428e-b00c-e0c905659ecd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849385amantadine HCl 50 MG in 5 mL Oral SolutionPSN7ef565b0-00ac-428e-b00c-e0c905659ecd10
849385amantadine hydrochloride 10 MG/ML Oral SolutionSCD7ef565b0-00ac-428e-b00c-e0c905659ecd10
849385amantadine hydrochloride 100 MG per 10 ML Oral SolutionSY7ef565b0-00ac-428e-b00c-e0c905659ecd10
849385amantadine hydrochloride 50 MG per 5 ML Oral SolutionSY7ef565b0-00ac-428e-b00c-e0c905659ecd10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-807-105038308071010 mL in 1 CUP, UNIT-DOSE10 mlHistorical
50383-807-125038308071210 TRAY in 1 CASE (50383-807-12) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-807-10) 10 tray2014-06-040000-00-00NoNoCurrent
50383-807-1650383080716473 mL in 1 BOTTLE (50383-807-16) 473 ml1994-10-280000-00-00NoNoCurrent